82_FR_49024 82 FR 48822 - Current Good Manufacturing Practice Requirements for Food for Animals; Guidance for Industry; Availability

82 FR 48822 - Current Good Manufacturing Practice Requirements for Food for Animals; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 202 (October 20, 2017)

Page Range48822-48823
FR Document2017-22730

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #235 entitled ``Current Good Manufacturing Practice Requirements for Food for Animals.'' This guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.

Federal Register, Volume 82 Issue 202 (Friday, October 20, 2017) 
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48822-48823]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22730]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1229]


Current Good Manufacturing Practice Requirements for Food for 
Animals; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry #235 entitled ``Current 
Good Manufacturing Practice Requirements for Food for Animals.'' This 
guidance helps domestic and foreign facilities that are required to 
register as food facilities under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) determine whether and how they need to comply with 
the current good manufacturing practice requirements of the Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Food for Animals final rule.

DATES: The announcement of the guidance is published in the Federal 
Register on October 20, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1229 for ``Current Good Manufacturing Practice Requirements

[[Page 48823]]

for Food for Animals.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff office between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary 
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6246, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 25, 2016 (81 FR 58519), FDA 
published the notice of availability for a draft guidance entitled 
``Current Good Manufacturing Practice Requirements for Food for 
Animals,'' giving interested persons until November 23, 2016, to 
comment on the draft guidance. FDA received comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. Changes made include additional explanation and examples and 
the inclusion of a part 507 (21 CFR part 507) Current Good 
Manufacturing Practice (CGMP) Self-Assessment Tool in Appendix B to 
assist facilities in reviewing the implementation of CGMP requirements 
at their facility. Information regarding human food by-products for use 
as food for animals was removed; this information is contained in draft 
GFI #239, entitled ``Human Food By-Products for Use as Animal Food'' 
(81 FR 58521, August 25, 2016). In addition, editorial changes were 
made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated August 2016.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on current good manufacturing practice 
requirements for food for animals. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 507 have been approved under OMB 
control number 0910-0789.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: October 16, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22730 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P

48822 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices collection under 45 CFR 1355.41–.47 to forth the requirements of section 479 of consortia that choose to operate a foster be implemented October 1, 2019. the Social Security Act for the collection care, adoption assistance and, at Tribal Commenters addressed support for the of uniform, reliable information on option, a kinship guardianship collection of information under the children who are under the assistance program under title IV–E of Indian Child Welfare Act and other responsibility of the State or Tribal title the Act. The data collected informs areas covered by the new requirements. IV–B/IV–E agency for placement, care, State/Tribal/Federal policy decisions, ACF received no comment on the and adoption. The AFCARS program management, and responses to specific burden hours for the existing requirements under 45 CFR 1355.40 Congressional and Departmental AFCARS requirements undergoing have been in effect since October 1, inquiries. renewal. 1993 for States. In 2009, section 479B(b) AFCARS is mandated by 42 U.S.C. of the Act was enacted authorizing Respondents: Title IV–E State and 679. The regulation at 45 CFR 1355.40 direct Federal funding of Indian Tribes, Tribal Child Welfare Agencies. and the appendices to 45 CFR 1355 set Tribal organizations, and Tribal ESTIMATED TOTAL ANNUAL BURDEN HOURS Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response AFCARS .......................................................................................................... 59 2 2,188 258,215 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 258,215 Additional Information: Copies of the DEPARTMENT OF HEALTH AND Comments submitted electronically, regulation containing the data elements HUMAN SERVICES including attachments, to https:// may be obtained by writing to the www.regulations.gov will be posted to Administration for Children and Food and Drug Administration the docket unchanged. Because your Families, Office of Planning, Research [Docket No. FDA–2016–D–1229] comment will be made public, you are and Evaluation, 330 C Street SW., solely responsible for ensuring that your Washington, DC 20201. Attention Current Good Manufacturing Practice comment does not include any Reports Clearance Officer. All requests Requirements for Food for Animals; confidential information that you or a should be identified by the title of the Guidance for Industry; Availability third party may not wish to be posted, such as medical information, your or information collection. Email address: AGENCY: Food and Drug Administration, anyone else’s Social Security number, or infocollection@acf.hhs.gov. HHS. confidential business information, such OMB Comment: OMB is required to ACTION: Notice of availability. as a manufacturing process. Please note make a decision concerning the that if you include your name, contact SUMMARY: The Food and Drug collection of information between 30 information, or other information that Administration (FDA or Agency) is and 60 days after publication of this identifies you in the body of your announcing the availability of a document in the Federal Register. comments, that information will be guidance for industry #235 entitled Therefore, a comment is best assured of posted on https://www.regulations.gov. ‘‘Current Good Manufacturing Practice having its full effect if OMB receives it • If you want to submit a comment Requirements for Food for Animals.’’ within 30 days of publication. Written with confidential information that you This guidance helps domestic and do not wish to be made available to the comments and recommendations for the foreign facilities that are required to proposed information collection should public, submit the comment as a register as food facilities under the written/paper submission and in the be sent directly to the following: Office Federal Food, Drug, and Cosmetic Act manner detailed (see ‘‘Written/Paper of Management and Budget, Paperwork (the FD&C Act) determine whether and Submissions’’ and ‘‘Instructions’’). Reduction Project, Email: OIRA_ how they need to comply with the SUBMISSION@OMB.EOP.GOV, Attn: current good manufacturing practice Written/Paper Submissions Desk Officer for the Administration for requirements of the Current Good Submit written/paper submissions as Children and Families. Manufacturing Practice, Hazard follows: Analysis, and Risk-Based Preventive • Mail/Hand delivery/Courier (for Mary Jones, Controls for Food for Animals final rule. written/paper submissions): Dockets ACF/OPRE Reports Clearance Officer. DATES: The announcement of the Management Staff (HFA–305), Food and [FR Doc. 2017–22720 Filed 10–19–17; 8:45 am] guidance is published in the Federal Drug Administration, 5630 Fishers BILLING CODE 4184–25–P Register on October 20, 2017. Lane, Rm. 1061, Rockville, MD 20852. ADDRESSES: You may submit either • For written/paper comments electronic or written comments on submitted to the Dockets Management Agency guidances at any time as Staff, FDA will post your comment, as srobinson on DSKBC5CHB2PROD with NOTICES follows: well as any attachments, except for information submitted, marked and Electronic Submissions identified, as confidential, if submitted Submit electronic comments in the as detailed in ‘‘Instructions.’’ following way: Instructions: All submissions received • Federal eRulemaking Portal: must include the Docket No. FDA– https://www.regulations.gov. Follow the 2016–D–1229 for ‘‘Current Good instructions for submitting comments. Manufacturing Practice Requirements VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48823 for Food for Animals.’’ Received FOR FURTHER INFORMATION CONTACT: https://www.fda.gov/AnimalVeterinary/ comments will be placed in the docket Jeanette Murphy, Center for Veterinary GuidanceComplianceEnforcement/ and, except for those submitted as Medicine (HFV–200), Food and Drug GuidanceforIndustry/default.htm or ‘‘Confidential Submissions,’’ publicly Administration, 7519 Standish Pl., https://www.regulations.gov. viewable at https://www.regulations.gov Rockville, MD 20855, 240–402–6246, Dated: October 16, 2017. or at the Dockets Management Staff Jenny.Murphy@fda.hhs.gov. Anna K. Abram, office between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: Deputy Commissioner for Policy, Planning, Monday through Friday. I. Background Legislation, and Analysis. • Confidential Submissions—To submit a comment with confidential [FR Doc. 2017–22730 Filed 10–19–17; 8:45 am] In the Federal Register of August 25, information that you do not wish to be 2016 (81 FR 58519), FDA published the BILLING CODE 4164–01–P made publicly available, submit your notice of availability for a draft guidance comments only as a written/paper entitled ‘‘Current Good Manufacturing submission. You should submit two Practice Requirements for Food for DEPARTMENT OF HEALTH AND copies total. One copy will include the Animals,’’ giving interested persons HUMAN SERVICES information you claim to be confidential until November 23, 2016, to comment Food and Drug Administration with a heading or cover note that states on the draft guidance. FDA received ‘‘THIS DOCUMENT CONTAINS comments on the draft guidance and [Docket No. FDA–2007–D–0369] CONFIDENTIAL INFORMATION.’’ The those comments were considered as the Agency will review this copy, including guidance was finalized. Changes made Product-Specific Guidances for the claimed confidential information, in include additional explanation and Salmeterol Xinafoate and Fluticasone its consideration of comments. The examples and the inclusion of a part 507 Propionate; Draft Guidances for second copy, which will have the (21 CFR part 507) Current Good Industry; Availability claimed confidential information Manufacturing Practice (CGMP) Self- AGENCY: Food and Drug Administration, redacted/blacked out, will be available Assessment Tool in Appendix B to HHS. for public viewing and posted on assist facilities in reviewing the https://www.regulations.gov. Submit ACTION: Notice of availability. implementation of CGMP requirements both copies to the Dockets Management at their facility. Information regarding SUMMARY: The Food and Drug Staff. If you do not wish your name and human food by-products for use as food Administration (FDA or Agency) is contact information to be made publicly for animals was removed; this announcing the availability of three available, you can provide this information is contained in draft GFI draft guidances for industry on generic information on the cover sheet and not #239, entitled ‘‘Human Food By- salmeterol xinafoate inhalation powder, in the body of your comments and you Products for Use as Animal Food’’ (81 fluticasone propionate inhalation must identify this information as FR 58521, August 25, 2016). In addition, aerosol, and fluticasone propionate ‘‘confidential.’’ Any information marked editorial changes were made to improve inhalation powder, entitled ‘‘Draft as ‘‘confidential’’ will not be disclosed clarity. The guidance announced in this Guidance on Salmeteral Xinafoate’’ and except in accordance with 21 CFR 10.20 notice finalizes the draft guidance dated ‘‘Draft Guidance on Fluticasone and other applicable disclosure law. For August 2016. Propionate.’’ The guidances, when more information about FDA’s posting finalized, will provide product-specific of comments to public dockets, see 80 II. Significance of Guidance recommendations on, among other FR 56469, September 18, 2015, or access This level 1 guidance is being issued things, the design of bioequivalence the information at: https://www.gpo.gov/ consistent with FDA’s good guidance (BE) studies to support abbreviated new fdsys/pkg/FR-2015-09-18/pdf/2015- practices regulation (21 CFR 10.115). drug applications (ANDAs) for 23389.pdf. The guidance represents the current salmeterol xinafoate inhalation powder, Docket: For access to the docket to thinking of FDA on current good fluticasone propionate inhalation read background documents or the manufacturing practice requirements for aerosol, and fluticasone propionate electronic and written/paper comments food for animals. It does not establish inhalation powder. received, go to https:// any rights for any person and is not www.regulations.gov and insert the DATES: Submit either electronic or binding on FDA or the public. You can docket number, found in brackets in the written comments on the draft use an alternative approach if it satisfies heading of this document, into the guidances by December 19, 2017 to the requirements of the applicable ‘‘Search’’ box and follow the prompts ensure that the Agency considers your statutes and regulations. This guidance and/or go to the Dockets Management comment on this draft guidance before is not subject to Executive Order 12866. Staff, 5630 Fishers Lane, Rm. 1061, it begins work on the final version of the Rockville, MD 20852. III. Paperwork Reduction Act of 1995 guidance. You may submit comments on any This guidance refers to previously ADDRESSES: You may submit comments guidance at any time (see 21 CFR approved collections of information on any guidance at any time as follows: 10.115(g)(5)). found in FDA regulations. These Submit written requests for single Electronic Submissions collections of information are subject to copies of the guidance to the Policy and review by the Office of Management and Submit electronic comments in the Regulations Staff (HFV–6), Center for Budget (OMB) under the Paperwork following way: Veterinary Medicine, Food and Drug • Federal eRulemaking Portal: srobinson on DSKBC5CHB2PROD with NOTICES Reduction Act of 1995 (44 U.S.C. 3501– Administration, 7500 Standish Pl., 3520). The collections of information in https://www.regulations.gov. Follow the Rockville, MD 20855. Send one self- part 507 have been approved under instructions for submitting comments. addressed adhesive label to assist that OMB control number 0910–0789. Comments submitted electronically, office in processing your requests. See including attachments, to https:// the SUPPLEMENTARY INFORMATION section IV. Electronic Access www.regulations.gov will be posted to for electronic access to the guidance Persons with access to the internet the docket unchanged. Because your document. may obtain the guidance at either comment will be made public, you are VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1


Document Created: 2017-10-20 00:06:33
Document Modified: 2017-10-20 00:06:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on October 20, 2017.
ContactJeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, [email protected]
FR Citation82 FR 48822 
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